What is a Preventive Action?
Preventive Action Definition
Preventive action is a system to eliminate any cause(s) that would create a potential hazard or undesirable situation. Changes can be made or implemented to address an issue, hazard, or weakness in a system. Preventive action also can include ways to improve an organization’s workflow or situation. A good preventive action process includes controls to make sure the preventive actions are in place and working and can differ from one company or organization to another.
FAQs
How do you write a preventive action plan?
A preventive action plan should include:
- Description of the issue
- Documented root cause analysis
- Evaluation of the risk and opportunities of the preventive measure
- Steps needed to prevent the issue
- Implementation (i.e., allocation of resources, steps needed for execution, timeline, cost, etc.)
- Follow-up measures (i.e., verification of effectiveness)
*Source: https://advisera.com/blog/2021/07/19/complete-guide-to-corrective-action-vs-preventive-action/
What is difference between corrective action and preventive action?
Corrective actions are a set of actions taken to rectify or change a process that causes errors or nonconforming events. Preventive actions are proactive measures that are taken to prevent nonconformities from occurring in the future.
Why are Capas important?
Corrective and preventive actions (CAPAs) help organizations improve their processes and prevent undesirable situations and nonconformities from occurring. CAPAs provide a systematic method for problem solving, ensure quality issues are resolved, reduce customer complaints, reduce scrap and rework costs, promote continuous improvement, and help organizations meet regulatory requirements.
*Source: https://www.propharmagroup.com/blog/why-capa-so-important-anyway-0/
What is an example of preventive action?
Examples of preventive actions include:
- Implementing training programs for employees
- Reviewing or auditing suppliers
- Developing disaster recovery plans
*Source: https://i-sight.com/resources/building-an-effective-capa-plan-your-8-step-guide/
Best
Practice
Medical device companies must have a compliant Corrective Action Preventive Action (CAPA) process in place to comply with FDA 21 CFR 820.100. A collaborative quality system lets you check this FDA requirement “box” while facilitating corporate objectives. Learn the 5 essential elements of a CAPA system.